User Fee Collections

MDUFMA directs FDA to receive fees from medical device applications as well as annual establishment registration fees and periodic report fees through FY 2012. The statute directs FDA to set the fee rate for each application type and for periodic reports as a percentage of the standard fee for a PMA. For FY 2009, MDUFMA specifies that the standard fee for a PMA is $200,725 and that the device establishment fee is $1,851. FDA then sets the other fees based on the percentages specified in the statute.

Under MDUFMA, medical device user fees continue to remain available to FDA for use in future years for the medical device review process if they are not obligated at the end of the fiscal year. The cash balances carried to the next fiscal year are provided in the tables on page 5, in the section CARRYOVER BALANCES. The table below shows the amount of user fees FDA has collected over the most recent 2 fiscal years.

FOOD AND DRUG ADMINISTRATIONSTATEMENT OF MEDICAL DEVICE FEE COLLECTIONS AS OF SEPTEMBER 30, 2009

FY 2008

FY 2009

Total Fees Collected

$49,157,896

$62,011,733

Unearned Fees (1)

$1,585,576

$5,610,279

Fees Receivable

$3,992,537

$336,982

(1) Unearned Fees are fees collected for applications that had not been received by FDA as of September 30, 2009 or for FY 2009 establishment fees received without identification of the remitter. They are included above in the 'Total Fees Collected' amounts.

Note that user fees collected (the first line in the table) are initially credited to the year the fee is received. However, the revenues may be reassigned to the year the application is received, if that is different. This is referred to as the cohort year. Last year’s report showed $49,080,016 of fees collected in FY 2008, of which $3,720,696 was shown as “unearned income” since the application for which the fee was paid had not been received by the end of FY 2008. The FY 2008 total fees collected line is increased to $49,157,896 in this report, and all but $1,585,576 of the unearned income reported last year has now been either refunded or credited to the year the application was actually received. The total fees collected line for FY 2009, when seen in next year’s FY 2010 report, will also be different from the figure shown here—reflecting both the refund or reassignment of unearned income, and the refunds that will be made over the next 12 months. Totals reported for each year are net of any refunds for that year, as of September 30, but do not take into account any refunds that may be made after September 30. Information on the number of each type of fee received in FY 2009 is contained in Appendix B.

A summary of FY 2009 waivers, reductions, and exemptions is provided in Appendix C.